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To demonstrate the feasibility, safety and efficacy of the CryoBalloon Ablation System for the treatment of esophageal squamous cell dysplasia.
Multi-center, prospective, single arm, non-randomized study. The study will proceed in two phases: a pilot phase, followed by the feasibility, safety and efficacy phase. In the pilot phase, up to five (5) patients at one (1) site will be treated with the CryoBalloon Ablation System to confirm its safety and feasibility in the treatment of squamous dysplasia. The second phase will be conducted at two (2) centers and will enroll up to 50 subjects to evaluate the feasibility, safety and efficacy of the CryoBalloon Ablation System for the treatment of squamous dysplasia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CryoBalloon Focal Ablation System | Experimental | CryoBalloon Focal Ablation for the treatment of esophageal squamous cell dysplasia |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CryoBalloon Focal Ablation System | Device | Positioned within the esophagus at the target location, the Balloon is simultaneously inflated and cooled with nitrous oxide. The nitrous oxide cools the inner Balloon surface. The Balloon remains stationary during the delivery of the nitrous oxide for the Cryoablation of Dysplastic Squamous Tissue in Patients with Esophageal Squamous Cell Dysplasia |
| Measure | Description | Time Frame |
|---|---|---|
| Serious, device-related adverse events | Incidence of serious, device-related adverse events | Day 30 |
| Successful, complete ablation of the unstained lesions (USLs) within the treatment area (TA) | The percentage of subjects with successful, complete ablation of the USLs within the TA as determined by the endoscopist at the time of the treatment endoscopy(s) | Day 0 |
| Percentage of subjects with absence of ULS containing medium-grade intraepithelial neoplasia (MGIN) or high-grade intraepithelial neoplasia (HGIN) within the original TA | Percentage of subjects with absence of ULS containing medium-grade intraepithelial neoplasia (MGIN) or high-grade intraepithelial neoplasia (HGIN) within the original TA at three (3) months following endoscopic cryoablation. This will be evaluated by visual endoscopic exam and two (2) biopsies negative for squamous epithelial dysplasia confirmed by histopathological analysis | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Absence of USLs containing MGIN, HGIN or cancer | Efficacy defined as the absence of USLs containing MGIN, HGIN or cancer within the original TA after the last endoscopic ablation. | 12 months |
| Complete eradication after one treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guiqi Wang, MD | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences | Beijing | 100021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30922862 | Derived | Ke Y, van Munster SN, Xue L, He S, Zhang Y, Dou L, Liu Y, Liu X, Liu Y, Li W, Lv N, Dawsey SM, Weusten BLAM, Bergman JJGHM, Wang G. Prospective study of endoscopic focal cryoballoon ablation for esophageal squamous cell neoplasia in China. Gastrointest Endosc. 2019 Aug;90(2):204-212. doi: 10.1016/j.gie.2019.03.017. Epub 2019 Mar 25. |
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Percentage of subjects achieving complete eradication after one treatment session with the CryoBalloon Ablation System
| 12 months |
| Device performance | Device performance, assessed by Device malfunction | Day 0 |
| Procedure time | Procedure time, defined as the time from the introduction of the endoscope to its removal | Day 0 |
| Adverse Events | Incidence of all treatment-related and serious, non-device related adverse events | 12 Months |